BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective:To discuss the efficacy and safety of ultrasound-guided rectus sheath block (RSB) combined with subcostal transversus abdominis plane block(TAPB) in peritoneal dialysis catheter implantation in patients with end-stage renal disease.Methods:A total of sixty patients (scheduled for elective peritoneal dialysis catheter placement from June 2018 to March 2019 in Wuhan First Hospital were randomly divided into two groups: local anesthesia group(group LA, 30 patients) and ultrasound-guided RSB combined with subcostal TAPB (group NB, 30 patients). Group LA: local infiltration anesthesia was performed with 1% lidocaine and 0.5% ropivacaine 20ml; group NB: RSB, 1% lidocaine and 0.5% ropivacaine 15 ml were injected into the lateral rectus sheath, and TAPB, 1% lidocaine and 0.5% ropivacaine 20 ml were injected into the transversus abdominis plane. Mean arterial blood pressure (MAP) and heart rate (HR) were recorded at the point of entering the operating room (T 0), after anaesthesia (T 1), at the beginning of operation (T 2), twenty minutes after the beginning of operation (T 3), and at the end of the operation (T 4). The duration of operation, the times of additional local anesthetia during the surgery, the score of visual analogue scale (VAS) during and 24 h after the surgery, the rate of alteration to general anesthesia and the occurrence of adverse reactions were recorded. Results:In group LA, compared with T 0, MAP and HR at T 2 and T 3 increased significantly: (93.1 ± 9.7), (99.8 ± 11.6) times/min vs. (78.4 ± 10.5) times/min and (105.1 ± 13.7), (110.5 ± 14.4) mmHg (1 mmHg = 0.133 kPa) vs. (92.1 ± 12.8) mmHg, P<0.05. In group NB, there were no differences among T 0-T 4. At T 2 and T 3, MAP and HR in group LA were higher than those in group NB ( P<0.05). Compared with that in group LA, the duration of operation time decreased significantly in group NB ( P<0.05). The times of additional local anesthetia during the surgery in group LA were more than those in group NB ( P<0.05). Compared with those in group LA, the VAS scores during and 24 h after the surgery in group NB were significantly lower: (3.25 ± 0.65) scores vs. (5.85 ± 0.76) scores, (1.46 ± 0.57) scores vs. (2.37 ± 0.45) scores, P<0.05. There were no significant differences in the rate of alteration to general anesthesia between the two groups: 3.33% (1/30) vs. 0, P>0.05. There was no adverse reaction in these two groups. Conclusions:Ultrasound-guided rectus sheath block combined with subcostal transversus abdominis plane block is safe and effective in peritoneal dialysis catheter implantation. The effect of intraoperative anesthesia is definite, with little influence on hemodynamics. The postoperative analgesia effect is good, without obvious anaesthesia-related adverse events.

Objective To explore the value of plasma histones in predicting the prognosis of sepsis patients. Methods The patients with sepsis admitted to intensive care unit (ICU) of Subei People's Hospital of Jiangsu Province Affiliated to Yangzhou University from May 2016 to June 2018 were enrolled as the research subjects, and healthy volunteers were selected as healthy control at the same period. The plasma levels of histones, cardiac troponin I (cTnI), N-terminal pro-brain natriuretic peptide (NT-proBNP), sequential organ failure assessment (SOFA) score, lactate (Lac), procalcitonin (PCT) on admission 24 hours, and use of vasoconstrictor agents, the length of ICU stay and ICU mortality were recorded. The patients were divided into survival group and death group according to the prognosis, and the differences of each index between the two groups were compared. Multivariate binary Logistic regression analysis was carried out to identify the independent risk factors of death. The correlation between histone and the levels of cTnI, NT-proBNP, PCT and Lac was analyzed. The value of plasma histone, cTnI, NT-proBNP, PCT and Lac in predicting the prognosis of patients was analyzed by receiver operating characteristic (ROC) curve. According to the threshold value of histone in predicting prognosis, the patients were divided into two groups, and the differences of various indicators between the two groups were compared. Results ① A total of 93 sepsis patients were included, with 29 cases of ICU death, and the mortality was 31.2%. ② Compared with the healthy control group, histones, cTnI, NT-proBNP were significant increased, besides, histones, cTnI in the death group were further increased compared with the survival group;in addition, SOFA, proportion of vasoconstrictor use were also significant higher than those in the survival group [histones (mg/L): 0.33 (0.28,0.45) vs. 0.22 (0.17,0.29), cTnI (μg/L): 0.25±0.13 vs. 0.20±0.08, SOFA: 11 (8, 12) vs. 9 (8, 11), the rate of vasopressor use: 93.1% (27/29) vs. 68.8% (44/64), all P < 0.05]. Statistically significant indicators between the two groups were included in multivariate binary Logistic regression analysis. The result showed that the independent risk factors affecting the prognosis of patients were the rate of vasopressor use [odds ratio (OR) = 5.277, P = 0.043] and the level of histone (OR = 79.244, P = 0.036). ③ The plasma histone level were positively correlated with cTnI (r = 0.577, P = 0.000), SOFA (r = 0.469, P = 0.000), NT-proBNP (r = 0.349, P = 0.001) and Lac (r = 0.357, P = 0.000), while there was no significant correlation between histone and PCT (r = 0.133, P = 0.205). ④ ROC curve analysis showed that the area under ROC curve (AUC) of histone predicting prognosis was 0.769 (P = 0.000); when the cut-off point was 0.30 mg/L, the sensitivity and specificity were 72.4% and 81.2% respectively. The AUC of SOFA score was 0.653 (P = 0.018), and the sensitivity and specificity were 58.6% and 70.3% respectively when the cut-off point was 10.50; while cTnI, NT-proBNP, Lac and PCT had little value in predicting the prognosis of patients. ⑤ Compared with the group with histone level lower than 0.3 mg/L, the group with histones level greater than 0.3 mg/L had higher SOFA score, more doses of vasopressor, higher cTnI, NT-proBNP, Lac and PCT levels, and higher ICU mortality [SOFA: 11 (10, 12) vs. 9 (8, 10), use of vasopressor: 84.8% (28/33) vs. 76.7% (46/60), cTnI (μg/L): 0.28 (0.19, 0.32) vs. 0.18 (0.12, 0.22), NT-proBNP (ng/L): 3 624.0 (2 800.0, 5 260.0) vs. 2 512.0 (1 361.8, 3 590.8), Lac (mmol/L): 2.25 (1.85, 3.50) vs. 1.60 (1.25, 2.35), PCT (μg/L): 2.10 (1.30, 4.03) vs. 1.60 (1.26, 2.33), ICU mortality: 48.5% (16/33) vs. 21.7% (13/60), all P < 0.05], while no statistical difference in the length of ICU stay was found. Conclusions The independent risk factors for ICU mortality of sepsis patients were high histone level and the use of vasopressor. Plasma histone can be regarded as an indicator in predicting the prognosis of patients with sepsis.

Objective: To investigate the epidemiology and independent risk factors of septic cardiomyopathy. Methods: A prospective study was conducted. Patients with sepsis in intensive care unit (ICU) of Subei People's Hospital of Jiangsu Province, Yangzhou University, Fuxing Hospital, Capital Medical University and Beijing Electric Power Hospital from May 2016 to August 2019 were enrolled. All patients received standardized treatments according to the Surviving Sepsis Campaign (SSC) guidelines. Blood were collected within 24 hours of admission to ICU, and plasma histone H4, cardiac troponin I (cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) were detected by enzyme linked immunosorbent assay (ELISA). Transthoracic echocardiography was performed to record the ultrasonic parameters within 24 hours after admission. Sequential organ failure assessment (SOFA) score, usage of vasopressor drugs, and the prognosis of ICU were recorded. Patients were divided into two groups according to whether cardiomyopathy occurred or not, and the differences of each index between the two groups were compared. The correlation between plasma histone H4 and SOFA score, cTnI, NT-proBNP were investigated. Multivariate binary Logistic regression was used to determine the risk factors for septic cardiomyopathy. The predictive value of histone H4 in septic cardiomyopathy was shown by the receiver operating characteristic (ROC) curve. Results: 121 patients were included in this study, and there were 60 patients (49.6%) with septic cardiomyopathy. Thirty-six patients died, with an ICU mortality of 29.8%. ① Correlation analysis showed that plasma histone H4 in patients with septic cardiomyopathy was positively correlated with cTnI, SOFA score and NT-proBNP (r value was 0.512, 0.403 and 0.274, respectively, all P < 0.01). ② Compared with the non-cardiomyopathy group, the plasma histone H4, cTnI, usage of vasopressor drugs, SOFA score and ICU mortality in the cardiomyopathy group were significantly increased [histone H4 (mg/L): 0.26 (0.23, 0.30) vs. 0.22 (0.17, 0.27), cTnI (μg/L): 0.21 (0.17, 0.30) vs. 0.18 (0.14, 0.22), usage of vasopressor drugs: 83.3% (50/60) vs. 65.6% (40/61), SOFA score: 11 (9, 12) vs. 9 (8, 10), ICU mortality: 40.0% (24/60) vs. 19.7% (12/61), all P < 0.05]. Multivariate binary Logistic regression analysis showed that high histone H4 level [odds ratio (OR) = 6.502, 95% confidence interval (95%CI) was 1.203-78.231, P = 0.044] and usage of vasopressor drugs (OR = 2.622, 95%CI was 1.034-6.849, P = 0.042) were independent risk factors for septic cardiomyopathy. ④ ROC curve analysis showed the cut-off of histones H4 for predicting septic cardiomyopathy was 0.24 mg/L, the area under the curve was 0.684 (P < 0.01), with the sensitivity of 65.2%, and specificity of 68.9%. Conclusions Septic cardiomyopathy had a high incidence. Higher plasma histone H4 and the usage of vasopressor drugs were independent risk factors for septic cardiomyopathy.

OBJECTIVE: To investigate the epidemiology and independent risk factors of septic cardiomyopathy. METHODS: A prospective study was conducted. Patients with sepsis in intensive care unit (ICU) of Subei People's Hospital of Jiangsu Province, Yangzhou University, Fuxing Hospital, Capital Medical University and Beijing Electric Power Hospital from May 2016 to August 2019 were enrolled. All patients received standardized treatments according to the Surviving Sepsis Campaign (SSC) guidelines. Blood were collected within 24 hours of admission to ICU, and plasma histone H4, cardiac troponin I (cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) were detected by enzyme linked immunosorbent assay (ELISA). Transthoracic echocardiography was performed to record the ultrasonic parameters within 24 hours after admission. Sequential organ failure assessment (SOFA) score, usage of vasopressor drugs, and the prognosis of ICU were recorded. Patients were divided into two groups according to whether cardiomyopathy occurred or not, and the differences of each index between the two groups were compared. The correlation between plasma histone H4 and SOFA score, cTnI, NT-proBNP were investigated. Multivariate binary Logistic regression was used to determine the risk factors for septic cardiomyopathy. The predictive value of histone H4 in septic cardiomyopathy was shown by the receiver operating characteristic (ROC) curve. RESULTS: 121 patients were included in this study, and there were 60 patients (49.6%) with septic cardiomyopathy. Thirty-six patients died, with an ICU mortality of 29.8%. (1) Correlation analysis showed that plasma histone H4 in patients with septic cardiomyopathy was positively correlated with cTnI, SOFA score and NT-proBNP (r value was 0.512, 0.403 and 0.274, respectively, all P < 0.01). (2) Compared with the non-cardiomyopathy group, the plasma histone H4, cTnI, usage of vasopressor drugs, SOFA score and ICU mortality in the cardiomyopathy group were significantly increased [histone H4 (mg/L): 0.26 (0.23, 0.30) vs. 0.22 (0.17, 0.27), cTnI (μg/L): 0.21 (0.17, 0.30) vs. 0.18 (0.14, 0.22), usage of vasopressor drugs: 83.3% (50/60) vs. 65.6% (40/61), SOFA score: 11 (9, 12) vs. 9 (8, 10), ICU mortality: 40.0% (24/60) vs. 19.7% (12/61), all P < 0.05]. Multivariate binary Logistic regression analysis showed that high histone H4 level [odds ratio (OR) = 6.502, 95% confidence interval (95%CI) was 1.203-78.231, P = 0.044] and usage of vasopressor drugs (OR = 2.622, 95%CI was 1.034-6.849, P = 0.042) were independent risk factors for septic cardiomyopathy. (4) ROC curve analysis showed the cut-off of histones H4 for predicting septic cardiomyopathy was 0.24 mg/L, the area under the curve was 0.684 (P < 0.01), with the sensitivity of 65.2%, and specificity of 68.9%. CONCLUSIONS Septic cardiomyopathy had a high incidence. Higher plasma histone H4 and the usage of vasopressor drugs were independent risk factors for septic cardiomyopathy.
Cardiomyopathies ; Histones/blood* ; Humans ; Intensive Care Units ; Organ Dysfunction Scores ; Prognosis ; Prospective Studies ; ROC Curve ; Retrospective Studies ; Risk Factors ; Sepsis

Objective To assess the efficacy and safety of multimodal analgesia with different doses of nalbuphine combined with flurbiprofen on patients who received intravenous patient -controlled analgesia(PCIA) after thoracotomy.Methods Sixty patients underwent thoracotomy,ASA Ⅰ -Ⅱ,18 -65 years old,who underwent postoperative PCIA,were randomly divideded into three groups according to the digital table,nalbuphine 60 mg group (N60 group),nalbuphine 80 mg group(N80 group)and nalbuphine 100 mg group (N100 group),20 cases in each group.All patients were given 150mg flurbiprofen,a total of 100mL.PCIA solution:the background dose was 2mL/h, PCIA dose of 0.5mL,locking time of 15min.10min before surgery,each patient was intravenously given flurbiprofen 50mg,given a loading dose of 0.1mL/kg when closed chest.All patients were followed up for 48h.The incidence of adverse reactions such as vital signs,number of times,visual analog scale(VAS)score,sedation score,nausea and vomiting were recorded.Results There were no significant differences in the age,gender,body mass index and surgery duration among the three groups(all P >0.05).The vital signs were stable within 48h after operation.The VAS scores of N60 group were higher than the other two groups(N80 group:t =7.94,6.35,6.49,5.21,5.63,all P =0.00;N100 group:t =8.41,9.10,5.80,8.07,8.18,all P =0.00)at 4,6,8,24 and 48h after operation(all P <0.05).The VAS score of N80 group 48 h after operation was lower than that of N100 group(t =2.30,P =0.03),and the difference was not statistically significant in remaining(all P >0.05).The effective /actual compression ratio of PCIA of N80 group and N100 group were significantly higher than that of N60 group (t =7.30,8.35,all P <0.05). There were no differences in the incidence of adverse reaction among the three groups(group N80:χ2 =0.17,0.23, 1.03,all P >0.05;group N100:χ2 =3.14,0.23,1.03,all P >0.05).Conclusion Postoperative PCIA with nalbu-phine (80 mg)combined with flurbiprofen(150 mg)has significant analgesic effect and lower costs.

Objective To assess the efficacy and safety of nalbuphine in preventing the side effect of pruritus induced by intrathecal morphine after cesarean section. Methods Sixty patients aged 18- 35 years with ASAⅠ~Ⅱand undergoing cesarean section with combined spinal-epidural anesthesia were randomly and double blindly divided into two groups. Patients in Group N (30 patients) received nalbuphine 4 mg (2 ml) by intravenous route after clamping of the umbilical cord; Patients in Group P (30 patients) received 0.9% NaCl (2 ml) by intravenous route after clamping of the umbilical cord. The protocol of postoperative analgesia was intrathecal morphine 0.2 mg. The patients were followed up for 4 h , and the vital signs were detected at the time of returning to patient s room (T0), 1 h (T1), 2 h(T2), 3 h(T3) and 4 h(T4) after operation. The VAS scores, pruritus severity scores, time of pruritus onset, Ramsay sedation scores and and other adverse effects were recorded. Results The levels of MAP, SpO2, HR in two groups at T0, T1, T2, T3, T4 had no significant differences (P>0.05). The rate of pruritus severity score 0-1 score in group N was significantly higher than that in group P (χ2=17.4, P=0.00). The VAS scores and the rate of drowsiness, nausea, vomiting, shivering and dizziness in two groups had no significant difference (P>0.05). Conclusions Nalbuphine provides a significant reduction of morphine induced pruritus for patients who received intrathecal morphine analgesia after cesarean section.

Various functional proteins are differently expressed in each pathologic stage after spinal cord injury, representing injury and the pathological change of repair. Ideal biomarker is helpful to evaluate complicated biological reactions of spinal cord injury and predict prognosis. As specific serum markers of central nerve injury, neuron-specific enolase (NSE) and astrocyte primary calcium binding protein S-100β had been studied preliminarily, but the specificity and sensitivity need more research. Future efforts still need to develop ideal biomarkers to predict functional outcome.

Objective To assess the functional restoration in patients with developmental dysplasia of the hip (DDH) who underwent hip resurfacing arthroplasty and to determine whether greater abduction angle of the acetabular component is relat?ed to larger diameter of femoral head component. Methods We reviewed 34 DDH cases (9 hips of 8 males and 25 hips of 24 fe?males, mean age 44.6±11.85 years at the time of surgery) on whom we performed hip resurfacing arthroplasty (HRA) from October 2006 to September 2009. The total hip Arthroplasty (THA) group was consisted of 35 DDH cases (8 hips of 8 males and 27 hips of 25 females, mean age 43.7±10.4 years at the time of surgery). All operations were performed by the same doctor over the same peri?od. Assessment of the functional hip scores was conducted by Harris Hip Scores. A radiographic study was also performed to evalu?ate the implants stability and abduction angle of the acetabular components. All the data was analyzed with Kolmogorov?Smirnov method. Results The mean follow?up was 6.2 years in the HRA group. The Harris Hip Score improved from 54.9±13.2 to 97.3± 6.2 after the surgery. The mean abduction angle of the acetabular component was 51.6° ± 5.33°, hip flexion was 127° ± 6.9° and mean diameter of femoral head was 46.5±1.5 mm. The mean follow?up was 5.9 years in the THA group. The Harris Hip Score im?proved from 51.6±19.7 to 95.6±7.9 after the surgery. The mean abduction angle of the acetabular component was 43.9°±4.90°, hip flexion was 117°±4.2°. There was no failure of the prosthesis, peri?prosthetic fracture and infection in either group. There was sig?nificant difference in the abduction angle of the acetabular component (P<0.05) and flexion of the hip between the two groups (P<0.05). Conclusion Patients in the HRA group had a better functional restoration and larger range of motion. Furthermore, a larger diameter of femoral head component could be achieved by placing the acetabular component in a greater abduction angle, which may contribute to a better long?term stability.

Objective To study the effects of controlled hypotension with sevoflurane on hymo-dynamics and cerebral metabolic rate of oxygen in neurosurgery.Methods Thirty-seven ASA Ⅰ or Ⅱpatients undergoing elective intracranial surgery were enrolled.The patients were treated with general anesthesia and assigned to two experimental groups,sevoflurane group (group S,n=20)and sodium nitroprusside group (group N,n=1 7).HR,BP,SpO2 and ECG were continuously monitored during operation.Blood samples were taken from radial artery and internal jugular bulb to determine cerebral arteriovenous oxygen differences (Da-jvO2 ) and cerebral metabolic rate of oxygen (CMRO2 ). Results The HR in group S were decreased during hypotension,5 min,10 min,20 min,and 30 min compared with group N (P <0.05).Da-jvO2 and CMRO2 both in two groups were decreased during hypotension(P < 0.05 ),but there was no difference between the two groups.RPP was lower in group S than in group N during hypotension.Conclusion Controlled hypotension with sevoflurane does not increase HR and improves cerebral blood flow-metabolism coupling.